The primary objective of this SBIR effort is to develop a novel ultrathin (1~2 mm in diameter) scanning fiber endoscope (SFE) with simultaneous 2D/3D surface imaging capability. The proposed 3D-SFE will be able to provide, for the first time, dense 3D XYZ surface data that is co-registered with its 2D RGB counterpart, making 3D imaging an inherent part of SFE imaging capability without requiring users to perform any special manipulations or to take multiple images. The novel 3D imaging capability would greatly enhance the functionality of the existing SFE and enable it to perform, with its miniature probe size of 1~2 mm in diameter, a broad range of minimally invasive surgery procedures that were previously impossible to do. Unique features of the proposed novel 3D-SFE are: 7 High resolution full color 2D video image; 7 Unprecedented 3D imaging capability, with simultaneous and co-registered 2D and 3D image acquisition, possibly at video rate; 7 Single fiber scanner to generate stereo 3D images. 7 Dynamically adjustable field of view and image resolution; 7 Miniature size of the endoscope (~1 mm in diameter); 7 Extreme flexibility; and 7 Powerful 2D/3D image processing capability for minimally invasive surgeries. Xigen LLC proposes this comprehensive SBIR project, based on our strong collaborations and partnership with leading researchers/clinicians in multiple universities and hospitals. The Xigen team has long history and proven experience of attacking significant yet difficult 3D imaging problems in biomedical applications. Working closely with the research and clinical teams at the University of Washington who have developed multiple versions of working 2D scanning fiber endoscopes, we will develop full scale design, algorithms, hardware, software, and packaging for the 3D-SFE system, making it an integrated endoscopic image-guided system for minimally invasive surgeries that can access many sites that is currently impossible for existing endoscopes to do due to its ultra-thin diameter. This SBIR support will support thorough optical design, opto-electro-mechanical engineering development, 3D algorithmic development, and extensive tests. In Phase 1, the feasibility of the novel 3D-SFE will be thoroughly investigated. In Phase 2, working closely with clinical experts on our team, we will develop two fully functional 3D-SFE systems. We have streamlined our clinical study plan and focused on using 3D surface imaging capability for minimally invasive surgeries, such as otolaryngology surgeries (access sinus, middle ear, inner ear and skull based surgeries), and eye surgeries and drug placement on optic nerves. Proprietary Information of XIGEN LLC. 0 NIH SBIR PAR-09-220 PUBLIC HEALTH RELEVANCE: Minimally invasive surgeries (MIS) are procedures in which devices are inserted into the body through natural openings or small skin incisions to diagnose and treat/repair a wide range of medical conditions as an alternative to traditional open surgeries. Minimally invasive surgery has achieved pre-eminence for many general surgery procedures over the last two decades and has lead to reduced risk of complications, faster recovery with enhanced patient satisfaction due to reduced postoperative pain and favorable health system economics. Examples of minimally invasive procedures include: otolaryngology surgeries (access sinus, middle ear, inner ear and skull based surgeries), eye surgeries and drug placement on optic nerves, interventional cardiology procedures of balloon angioplasty and stenting; arthroscopic procedures, including knee, shoulder, small joint and hips; and laparoscopic procedures to examine, diagnose and treat problems of the abdomen. However, traditional endoscopes have many shortcomings in performing MIS: 7 Large Diameter of conventional endoscopes (4-13 mm) limits access regions where they can be used; 7 Limited Flexibility of current devices also prevents them from use in confined spaces; 7 Inadequate image quality of conventional endoscopes with small diameter to perform diagnosis or surgical interventions. 7 High Costs of high-resolution fiber bundle endoscopes as well as video-chip endoscopes; 7 Lack of 3D imaging capability, which is especially useful for sizing, diagnosis, registration of pre- operative and intra-operative images, and agile manipulation of instruments in confined spaces when conducting surgeries. Simultaneous 2D and 3D imaging capability would be useful in minimally invasive procedures, which require precise manipulation of multiple instruments. In addition, a method for accurate, real-time registration of endoscopic images with 3D data from CT and MRI images would be a significant advance in endoscopic interventions. Conventional video endoscopes (including the existing SFEs) acquire 2D images without the depth information that is needed for accurate registration with 3D pre-operative data. The ideal solution would be to acquire 3D images directly with the endoscope itself in real-time. 3D images can also enhance the endoscopist's visual feedback for manipulating and positioning the endoscope. Precise and quantitative sizing and 3D measurements are also crucial for surgical interventions. Additionally, the 3D surface from endoscopy optionally registered with CT and/or MR data would provide the endoscopist with better accuracy and more information for making decisions and performing minimally invasive procedures. The primary objective of this SBIR, therefore, is to develop and demonstrate a novel 3D imaging approach, specifically designed for the ultrathin scanning fiber endoscope (SFE) that enables unprecedented simultaneous 2D and 3D surface imaging capability. With pressing needs for effective endoscopic tools for minimally invasive surgeries, and multi-billion dollars spent every year world-wide in the MIS technologies, a practical, ultrathin, and low-cost 3D endoscope with high resolution, larger field of view (FOV), and unprecedented 2D and 3D imaging capability has a great potential for widespread medical and industrial applications.